Speakers

Speakers from Authorities, Inspectorates amd Associations

Dr Emer Cooke, European Medicines Agency (EMA)
Executive Director of the European Medicines Agency

Brendan Cuddy, European Medicines Agency (EMA)
Lead Scientific Officer at European Medicines Agency

Rick Friedman, US Food and Drug Administration (FDA)
Deputy Director, Manufacturing Quality at FDA

Dr Rainer Gnibl, Government of Upper Bavaria, Germany
GMP Inspector for the District Government and the EMA, Advisory Board member of EQPA

Mag.pharm. Andreas Kraßnigg, Austrian Agency for Health and Food Safety (AGES), Austria
Head Pharmaceutical Inspections and member of Annex 16 Drafting Group, Chair of the PIC/S Sub-Committee on Expert Circles and Advisory Board member of EQPA

Roelof Mol, Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd - IGJ), The Netherlands
Coordinating/specialist inspector

Speakers from Industry

Jyotsna Agnihotry, Flavine, Germany
Head of Quality Operations

Cheryl Chia, BeiGene, The Netherlands
Senior Director Distribution Quality and member of the EQPA Board of Directors

David Cockburn, EQPA and ECA, UK
Member of the EQPA Board of Directors and the ECA Executive Board. Former Chair of the EMA GMP/GDP IWG

Dr Carsten Coors, Vetter Development Services Austria
Qualified Person

Dr Susanne Ding, Boehringer Ingelheim, Germany
Qualified Person for Investigational Medicinal Products and member of the EQPA Board of Directors

Alessandro G. Giunta, AbbVie, Germany
Qualified Person, Associate Director IMP Quality Management

Georg Göstl, Takeda, Austria
QP, Chair of the Austrian QP Association aqpa and member of the EQPA Board of Directors

Tor Gråberg, EQPA, Sweden
Member of the EQPA Board of Directors. Former Head of the Drug Inspectorate at the Swedish Medical Products Agency and former PIC/S Chair

Rebecca Haywood, Pfizer, UK
Qualified Person

Cecilie Hejlskov, Syntese, Denmark
Operational Excellence Manager

Dr Arnoud Herremans, Y47 Consultancy, The Netherlands
Owner and Lean Kaizen Consultant

Katrien Himpens, J&J Innovative Medicine, Belgium
Qualified Person / Site Quality head, J&J Innovative Medicine, Belgium

Dr Afshin Hosseiny, ECA, France
Qualified Person, former Director of Global Quality, GSK. Chair of the ECA Executive Board

Dr Monika Hupfauf, Attorney-at Law, Austria
Lawyer with focus on the development of pharmaceuticals and medical products up to and including market entry

Patryk Jegorow, Takeda, Ireland
Qualified Person and Head of Quality Compliance and Systems Biologics Operating Unit

Canice Kearney, Takeda, Ireland
Qualified Person and Head of Quality, Biologics External Supply

Dr Ulrich Kissel, EQPA, Germany
Qualified Person and Chairman of the EQPA Board of Directors

Aidan Madden, FivePharma, Ireland
CEO

Sue Mann, Sue Mann Consultancy Ltd., UK
Qualified Person and QP Assessor working on behalf of the MHRA, representing the Royal Pharmaceutical Society

Madeleine Molster, Sagiure Legal, The Netherlands
Attorney at Law for International Employment Law, Contract Law and Governance. Member of the People's Committee, American Chamber of Commerce in the Netherlands (AmCham)

Shirley Murphy, Takeda, Ireland
Head Knowledge Management, Global Quality Compliance & Systems

Dr Umberto M. Musazzi, University of Milan, Italy
Fixed-term Research Fellow B, Department of Pharmaceutical Sciences

Sonsee Neu, Stress Counseling, Germany
Certified Mindful Life and NLP Coach Practitioner. Former actress

Dr Claudius Pop, Novartis, Germany
Head Clinical Supplies QA and Qualified Person

Gillian Renouf, Royal Pharmaceutical Society QP Assessment Panel, UK
Chair of the RPS QP Assessment Panel, Country Quality Head UK, Ireland and Nordics at Novartis

Dr Andreas Schwinn, Roche Pharma AG, Germany
Senior Qualified Person

Niina Taylor, EQPA, UK
IMP Working Group

Brenda Van Assche, J&J Innovative Medicine, Belgium
Qualified Person / Site Quality head, J&J Innovative Medicine, Belgium

Dr Markus Zeitz, Takeda, Switzerland
Head of Digital Quality

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